Narsampet, Warangal, Andhra Pradesh, India 3 Department of Chemistry,Gland Institute of Pharmaceutical Sciences,

Transcription

1 Page39 IJPBS Volume 1 Issue 1 JAN-MAR UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FINASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM Manish Kumar Thimmaraju* 1, Venkat Rao 2, Srikanth Gurrala 3, G Jayapal Reddy 4 1*,2 Central Analytical Laboratory, Balaji Institute of Pharmaceutical Sciences Narsampet, Warangal, Andhra Pradesh, India 3 Department of Chemistry,Gland Institute of Pharmaceutical Sciences, Narsapur, Medak, Andhra Pradesh, India 4 Department of Pharmaceutics,Tallapadmavathi College of Pharmacy, Orus, Warangal, Andhra Pradesh, India *Corresponding Author manishcancer@gmail.com Research Article RECEIVED ON ACCEPTED ON ABSTRACT A Simple, rapid, accurate and economical UV Spectrophotometric method is developed for determination of finasteride in bulk and tablets. In chloroform, the λmax of the drug was found to be 24 nm. Using UV instrument (analytical), in this proposed method finasteride follows linearity in the concentration range µg/ml with a correlation coefficient of Assay results were in good agreement with label claim. The methods were validated statistically and by recovery studies. The relative standard deviation was found to be with excellent precision and accuracy. KEYWORDS: Finasteride, U.V.Spectrometry, chloroform. Introduction Finasteride, N- (1,1-dimethylethyl) 3- oxo-4-aza-k-androst-1-ene-172-carboxamide. Finasteride, a type II alpha reductase inhibitor, slowly reduces prostatic volume, Prostate growth and function is influenced by dihydrotestosterone.alpha-reductase enzyme converts testosterone to dihydrotestosterone. Inhibition of alpha reductase results in decreased level of dihydrotestosterone leading to reduction of prostate size. Finasteride has higher affinity for -R type II versus type I. According to the literature survey it was found that few analytical methods such as Visible, UV,polarographic analysis, HPLC other methods were reported for Finasteride (Amer SM 2003, Amshumalli,M.K et al., 2001 Constanzer ML et al., 1991 Carlucci G et al., 1997,Carlin JR et al.,1998,k.ilango et al., 2002 ). The objective of the proposed methods to develop simple and accurate method for the determination of Finasteride by UV spectrophotometric method in Pharmaceutical dosages forms.

2 Page40 IJPBS Volume 1 Issue 1 JAN-MAR Structure Of Finasteride METHODS AND MATERIALS: Chemicals and Reagents Finasteride, Chloroform (A.R.GRADE), Tablet formulation (FINAST) Preparation of standard stock solution 100 mg of Finasteride was accurately weighed and dissolved in 100 ml of chloroform in 100ml volumetric flask to get the concentration about 1mg/ml stock solution. From the stock solution prepare serial dilutions from 0.1ml to 1.2 ml and transfer it to 10ml volumetric flasks. Dilute it with chloroform to get the concentrations ranging from 10µg/ml to 120µg/ml respectively. The absorbances were measured at max 24 nm against chloroform as a blank. The spectra was shown in FIG-1

3 Page41 IJPBS Volume 1 Issue 1 JAN-MAR Preparation of sample solution 20 tablets of marketed formulation containing Finasteride were taken and powdered. The powder equivalent to 100 mg of Finasteride was dissolved in 100 ml of chloroform, sonicated for 10 mins and filtered. From the above stock solution serial dilutions from 0.1 to 1.2ml were taken and transferred into 10ml TABLE -1 RESULTS OF ASSAY Drug Sample no labeled (mg/tab) estimated (mg/tab) volumetric flasks. The solutions were made up to the labelled volume with chloroform to get concentrations of about 10 to 120µg/ml respectively. The prepared solutions were measured at 24nm against chloroform as blank. Then the amount of drug present in the formulations was calculated. The results were shown in Table-1. % of label claim % deviation Finasteride (-) (-) (-) 0.9 TABLE -2 SUMMARY OF UV METHOD UV method Finasteride Absorption Maximum 24 Linearity Range ( g/ml) Slope Correlation Coefficient (r) % RSD of slope 6.76 Label claim (mg/tablet) found 4.92 S.D RSD% Standard Error % Recovery 99.7

4 Page42 IJPBS Volume 1 Issue 1 JAN-MAR Recovery studies: The recovery studies were carried out at three different levels i.e. 80%, 100% and 120% level. To ensure the reliability of the above method, recovery studies were carried out by mixing a TABLE -3 known quantity of standard drug with the preanalysed sample formulation and the contents were reanalyzed by the proposed method. The percentage recovery was found and shown in Table-3 Drug Added ( g/ml) recovered ( g/ml) Percentage recovery (%) Average Recovery %RSD Finasteride RESULTS AND DISCUSSION From the optical characteristics of the proposed method it was found that the drug obeys linearity within the concentration range of g/ml. From the results it was found that the percent RSD is less than 2% which indicates that the method has good reproducibility, the percent recovery values of pure drug from the preanalysed solutions of formulations were in between %, which indicates that the method is accurate and which reveals the commonly used excipients and additives present in the pharmaceutical formulations did not interfere in the proposed method. The proposed method was simple, sensitive and reliable with good precision and accuracy. The proposed method is specific while estimating the commercial formulations without interference of excipients and other additives. Hence, this method can be used for the routing determination of Finasteride in bulk samples and pharmaceutical formulations. ACKNOWLEDGEMENT I am very thankful to Balaji Institute of Pharmaceutical sciences, warangal, for giving permission to carry out my research work. I am very much thank full to professor and principal Dr.N.Raghunandan, Balaji Institute of Pharmaceutical sciences, Warangal, for his guidance, kind help and constant encouragement at every step during the progress of my work. I am also grateful to my scholars and my friends for their kind help from time to time at each step of this work. REFERENCES 1. Amer SM. 2003, Polarographic behaviour and determination of Finasteride. Farmaco feb; 8(2): Amshumali MK Syed A.A. 2001, The reversed phase-hplc assay of Finasteride in preformulation and its degradation studies. J pharm Biomed anal.jul:2(- 6) Barrish A Olah TV, Gilbert JD, Gerber TF, Meloughlin DA. 1994, A. sensitive and specific assay of Finasteride based on combined LC-MS/MS, J.Pharm Biomed anal may 12(): Beckett.A.H, Eds., 2001, Practical Pharmaceutical Chemistry, 4th Edn., CBS

5 Page43 IJPBS Volume 1 Issue 1 JAN-MAR Publishers and Distributors, New Delhi, pp Bennett P.N., Laurence D.R. Brown M.J, Clinical Pharmacology 8 th Edition; Budavari S., Eds 1994,The Merck Index, 12 th Edn., Merck & Co. Inc, White house Station, NJ,, Budavari S., Eds 1994., The Merck Index, 12 th Edn., Merck & Co. Inc, White house Station, NJ, Constanzer Ml, Chavbez CM, Matuszewski BK, Determination of Finasteride in human plasma. J.chromatoger B.Biomed App,.Aug.19:68(2): Carlin JR, christofalo P, Vandeenheuvel WJ. J Chromatogr High performance liquid chromatographic method for the quantitative determination of N-(2-methyl-2-propyl)-3-oxo-4-aza-alphaandrost-1ene-17 beta-caarboxamide in human plasma. J Chromatoger, may13:427)1): Carlucci G, mazzeo P, A highperformance liquid chromatographic method for the determination of Finasteride in human plasma. J Chromatoger b Biomed Sci App,may23:693(1): Doserge R.F., ed Wilson and Gisvold s text book of organic medicinal and pharmaceutical chemistry, 8 th edn, Lippincott company, Dale M.M Rang H.P Ritter J.M. Moore P.K pharmacology th Edition ; Dale M.M. Rang H.P. Ritter J.M. Moore P.K Pharmacology th Edition; Dale M.M. Rang H.P. Ritter J.M. Moore P.K., Pharmacology th Edition; Dale M.M. Rang H.P. Ritter J.M. Moore P.K Pharmacology th Edition; Foye Wiliam O 1989, Principles of medicinal chemistry, 3 rd Edn., Varghese Bombay Hardman J.G., Limbird, L.M., Good man, A and Gilman, 2001 The pharmacological basis of Therapeuties, 10 th, Edn, 198. *Address for the Correspondence: Manish Kumar Thimmaraju* 1 Assistant Professor, Central Analytical Laboratory, Balaji Institute of Pharmaceutical Sciences Narsampet, Warangal, Andhra Pradesh, India E.mail: manishcancer@gmail.com